Lung CancerNCT00900172
Study of Blood and Tissue Samples From Patients With Locally Advanced, Metastatic, or Recurrent Non-Small Cell Lung Cancer Treated With Bevacizumab, Carboplatin, and Paclitaxel
An observational study of Lung Cancer, run by ECOG-ACRIN Cancer Research Group.
Trial summary
RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- bevacizumab, carboplatin and paclitaxel
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2008to 15 Apr 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Samples submitted for research from patients participating in E4599
DISEASE CHARACTERISTICS:
- Available serum or plasma samples from patients with locally advanced, metastatic, or recurrent non-squamous non-small cell lung cancer
- Stage IIIB (with pleural effusion) or stage IV disease
- Enrolled on protocol ECOG-4599
- Treated with carboplatin and paclitaxel with or without bevacizumab
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior chemotherapy
About this study
Official title: Angiogenesis Pathway Gene Polymorphisms Associated With Clinical Outcome in Patients Enrolled in ECOG 4599
RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.
PURPOSE: This research study is looking at blood and tissue samples from patients with locally advanced, metastatic, or recurrent non-small cell lung cancer treated with bevacizumab, carboplatin, and paclitaxel.
Read the detailed description
OBJECTIVES:
Primary
- To determine whether germline polymorphisms (DNA) of genes involved in DNA repair (e.g., XPD, ERCC-1, and others) and angiogenesis (e.g., vascular endothelial growth factor [VEGF], interleukin-8, CXCR2, adrenomedullin, leptin, and others) are associated with toxicity and clinical outcome in patients with non-small cell lung cancer enrolled on protocol ECOG-4599.
OUTLINE: Blood samples previously obtained from patients on protocol ECOG-4599 are analyzed for the association of germline variations of genes involved in DNA repair (XPD and ERCC1), angiogenesis (VEGF and IL-8), and clinical outcome (overall survival, response, progression-free survival, and toxicity).
Tumor cells are collected from paraffin-embedded tissue using laser-capture microdissection and normal tissue is collected from the specimen. Polymorphisms in ERCC-1, XRCC-1, XRCC-3, GST-P1, TGF-β, and IL-8CXCR are assessed using Taqman assays.
- Conditions
- Lung Cancer
- Being tested
- bevacizumab, carboplatin, paclitaxel, gene expression analysis, polymerase chain reaction
- Keywords
- stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer, adenocarcinoma of the lung, bronchoalveolar cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of Lung, Adenocarcinoma, Bronchiolo-Alveolar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumabBiological
carboplatinDrug
paclitaxelDrug
gene expression analysisGenetic
polymerase chain reactionGenetic
polymorphism analysisGenetic
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of results to response and toxicity
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study start15 Mar 2008
- Primary completion15 Apr 2009
- Study completion15 Apr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by ECOG-ACRIN Cancer Research GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- ECOG-ACRIN Cancer Research Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Heinz-Josef Lenz, MD, Study chair, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00900172
- Sponsor's protocol ID
- CDR0000592945
- Other IDs
- ECOG-E4599T1
- Status last verified
- May 2017
- First submitted
- 9 May 2009
- Last updated
- 19 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Angiogenesis Pathway Gene Polymorphisms Associated With Clinical Outcome in Patients Enrolled in ECOG 4599
- ClinicalTrials.gov ID
- NCT00900172
- Acronym / sponsor ID
- CDR0000592945
- Conditions
- Lung Cancer
- Keywords
- stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer, adenocarcinoma of the lung, bronchoalveolar cell lung cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- ECOG-ACRIN Cancer Research GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 15 Mar 2008 (actual)
- Primary completion
- 15 Apr 2009 (actual)
- Study completion
- 15 Apr 2009 (actual)
- First posted
- 12 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.
PURPOSE: This research study is looking at blood and tissue samples from patients with locally advanced, metastatic, or recurrent non-small cell lung cancer treated with bevacizumab, carboplatin, and paclitaxel.
Detailed description
OBJECTIVES:
Primary
- To determine whether germline polymorphisms (DNA) of genes involved in DNA repair (e.g., XPD, ERCC-1, and others) and angiogenesis (e.g., vascular endothelial growth factor [VEGF], interleukin-8, CXCR2, adrenomedullin, leptin, and others) are associated with toxicity and clinical outcome in patients with non-small cell lung cancer enrolled on protocol ECOG-4599.
OUTLINE: Blood samples previously obtained from patients on protocol ECOG-4599 are analyzed for the association of germline variations of genes involved in DNA repair (XPD and ERCC1), angiogenesis (VEGF and IL-8), and clinical outcome (overall survival, response, progression-free survival, and toxicity).
Tumor cells are collected from paraffin-embedded tissue using laser-capture microdissection and normal tissue is collected from the specimen. Polymorphisms in ERCC-1, XRCC-1, XRCC-3, GST-P1, TGF-β, and IL-8CXCR are assessed using Taqman assays.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Samples submitted for research from patients participating in E4599
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bevacizumab | Biological | – |
| carboplatin | Drug | – |
| paclitaxel | Drug | – |
| gene expression analysis | Genetic | – |
| polymerase chain reaction | Genetic | – |
| polymorphism analysis | Genetic | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Correlation of results to response and toxicity
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heinz-Josef Lenz, MD study chair
University of Southern California
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by ECOG-ACRIN Cancer Research Group.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of results to response and toxicity (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2017.